Patient Medication Information: uses, side effects, how to take - Teva-Amlodipine (Teva Canada, 5 mg, 10 mg)
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-AMLODIPINE has been prescribed to you for:
- The treatment of high blood pressure (hypertension), or
- The management of a type of chest pain called angina. TEVA-AMLODIPINE can be used by itself or with other medicines to treat these conditions.
What it does:
TEVA-AMLODIPINE is a type of medicine known as a calcium channel blocker (CCB).
TEVA-AMLODIPINE relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. TEVA-AMLODIPINE controls chest pain by improving the supply of blood and oxygen to the heart and by reducing its workload.
When it should not be used:
Do not use TEVA-AMLODIPINE if you:
Are allergic to amlodipine (the active ingredient in
TEVA-AMLODIPINE), or to the inactive ingredients listed under “What the nonmedicinal ingredients are” below.
Have ever had an allergic reaction to a similar type of
drug.
- Have very low blood pressure (less than 90 mmHg systolic).
Have been diagnosed with aortic stenosis (narrowing of the
aortic heart valve).
Have been diagnosed with unstable heart failure after a heart
attack.
- Experience shock including cardiogenic shock.
Are breast-feeding. Do not breast-feed while taking TEVA-
AMLODIPINE.
What the medicinal ingredient is:
amlodipine besylate
What the nonmedicinal ingredients are:
calcium phosphate (dibasic) anhydrous, magnesium stearate microcrystalline cellulose, and sodium starch glycolate.
What dosage forms it comes in:
Tablets, 5 mg and 10 mg amlodipine
WARNINGS AND PRECAUTIONS
BEFORE you use TEVA-AMLODIPINE talk to your doctor, nurse or pharmacist if you:
- Ever had heart or blood vessel diseases.
- Have aortic stenosis (narrowing of a valve of your heart).
- Have liver or kidney problems.
Are pregnant, or plan to become pregnant.
TEVA-AMLODIPINE should not be used during pregnancy unless your doctor tells you otherwise.
- Are older than 65 years.
TEVA-AMLODIPINE may occasionally cause low blood pressure (hypotension). Your blood pressure should be carefully monitored, especially if you have had a stroke or take other drugs to lower your blood pressure.
If you take TEVA-AMLODIPINE together with a drug known as beta-blockers (e.g. acebutolol, atenolol, metoprolol, nadolol), do not suddenly stop using the beta-blocker. If your doctor advises you to discontinue use of the beta-blocker, your dose should be decreased slowly, as recommended by your doctor, before stopping it completely.
TEVA-AMLODIPINE is not recommended for use in children less than 6 years of age.
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines. Also mention if you drink alcoholic beverages.
Drug-Drug interaction:
Drugs that may interact with TEVA-AMLODIPINE include:
- Cyclosporin
- Clarithromycin, Erythromycin (antibiotic)
- Diltiazem
- Azole antifungals (e.g. ketoconazole, itraconazole)
- HIV protease inhibitors (e.g. ritonavir)
- Beta-blockers
- Sildenafil (VIAGRA)
Statin drugs used to treat high cholesterol (e.g. Simvastatin,
Atorvastatin)
- Tacrolimus (an anti-rejection drug)
- Sirolimus, temsirolimus, everolimus
- Dantrolene
Drug-Herb interaction:
- St-John Wort
Drug-Food interaction:
Do not eat grapefruit or drink grapefruit juice while on TEVA-AMLODIPINE.
PROPER USE OF THIS MEDICATION
Take TEVA-AMLODIPINE exactly as prescribed by your doctor, nurse or pharmacist. It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not stop taking your medication without having first informed your doctor.
Usual dose:
For both high blood pressure and chest pain, the recommended initial dose of TEVA-AMLODIPINE is 5 mg once daily. If necessary, your doctor may increase your dose to a maximum dose of 10 mg once daily.
Use in Patients with liver disease:
The starting dose is 2.5 mg once daily and can be gradually increased by your doctor.
Use in Children (6-17 years old):
The recommended dose is 2.5 mg to 5 mg once daily.
Overdose:
If you think you have taken too much TEVA-AMLODIPINE contact your doctor, nurse pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.
One or more of the following signs may occur in an overdose: Low blood pressure and rapid heartbeat.
Missed Dose:
If you miss a dose, take it as soon as you remember. If it has been more than 12 hours since you missed your last dose, skip the missed dose and continue with the next dose at your regular time. Do not take double doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects include:
- Headaches
- Tiredness, extreme sleepiness
- Stomach pain, nausea
- Dizziness
If any of these affects you severely, tell your doctor, nurse or pharmacist.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate emergency medical help | ||
| Only if severe | In all cases | |||
| Common | Flushing: Hot or warm feeling in your face | ✓ | ||
| Edema: Swelling of your legs or ankles | ✓ | |||
| Uncommon | Arrhythmia: Rapid, slow or irregular heartbeat | ✓ | ||
Increased frequency, severity, duration of angina: Pressing or squeezing pain in your chest | ✓ | |||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate emergency medical help | ||
| Only if severe | In all cases | |||
| Heart Attack: Pain, fullness and/or squeezing of the chest, jaw pain and/or arm pain, shortness of breath | ✓ | |||
| Liver Disorder: Yellowing of the skin or eye, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | |||
Allergic Reactions: Rash, hives, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing | ✓ | |||
Low Blood Pressure: Dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up | ✓ | |||
| Unknown | Extrapyramidal symptoms: Muscle stiffness, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want. | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking TEVA-AMLODIPINE, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
Keep out of the reach and sight of children.
Store bottles at 15°C - 30°C. Protect from light.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited by: Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com